Symphogen and Biovitrum Recruit First Patient for Phase II ITP Study
Symphogen and Biovitrum have announced the recruitment of the first patient into a Phase II clinical trial, initiated in June 2008 to evaluate the safety and efficacy, and explore the dose range of Sym001 in idiopathic thrombocytopenic purpura patients.
Up to 55 RhD-positive adult non-splenectomized patients with idiopathic thrombocytopenic purpura (ITP) will be enrolled in this first exploratory open label safety, efficacy and dose-finding trial.
The study objective is to evaluate the safety of Sym001 following a single intravenous dose. In addition, the study will determine the appropriate dose range in preparation for Phase III trials by assessing the increase in platelet levels and explore the mechanism of action of Sym001 by assessing its binding to red blood cells. Symphogen is sponsor for the Phase II study which is being conducted at 23 sites in Europe.
Sym001 is a recombinant, polyclonal anti-Rhesus D antibody product candidate. Symphogen and Biovitrum are jointly developing Sym001 under a 50/50 co-development and commercialization agreement announced in February 2006.
Martin Nicklasson, CEO of Biovitrum, said: “The potential of Sym001 as a new treatment modality for unmet medical needs fits well with Biovitrum’s specialist care and biopharma focus and strengths. Moreover, the initiation of this Phase II trial is a successful milestone in our working collaboration with Symphogen.”